Description
Responibilities:- Batch Record Review.
- Provide training in all aspects of Quality Management Systems and GMP.
- Deviation and CAPA process.
Site Audit Readiness activities for both internal and external audits. - Support preparation, review, approval and execution (where applicable) of site related documentation (Procedures, Forms, Transfer Strategies / Plans etc.)
- May be required to work a shift system in accordance with the operational needs of the business.
- Site Audit Readiness activities for both internal and external audits.
- SME for assigned quality systems providing ongoing guidance and direction to Associates at all levels in the organization.
- Education and Experience:
Education & Experience:
* Minimum qualification B.Sc Degree in one of the following disciplines: Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
* 4-6 Years or more post educational experience working in a regulated environment, preferably within a Pharma/Biotech facility
* Knowledge of EU/US quality related Biological/pharmaceutical/Medical Device regulations.
* Understanding/experience with a process and utility plant start-up would be an advantage
If you are interested in this position please contact Sarah Irvine on . Or if you know anyone who may be interested in this role, we offer £200 vouchers for any successful referrals.